腹膜透析用药背景下司维拉姆相关不良事件的信号挖掘与分析

Signal Mining and Analysis of Sevelamer-Related Adverse Events in the Context of Peritoneal Dialysis Medication

摘要: 目的：基于FAERS数据库，系统挖掘与量化评估司维拉姆在腹膜透析用药背景中的不良事件信号，识别潜在风险特征，为优化该用药背景下人群的临床安全用药决策提供循证依据。方法：提取美国FDA不良事件报告系统(FAERS)数据库中司维拉姆2004年第1季度到2025年第1季度数据，报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项伽马泊松收缩器(MGPS)对数据进行挖掘，并通过《国际医学用语词典》26.1版对ADE信号挖掘结果进行系统分类。结果：共检索到以司维拉姆为首要怀疑的ADE报告1002份，男女比例为1.3:1，患者年龄集中在18~85岁(73.1%)。检测到司维拉姆ADE信号983个，累及28个SOC。报告数前10位的PT中，说明书未记载的可疑阳性信号有3个，主要集中在代谢与营养类疾病、全身性疾病，以及给药部位反应和各种手术及医疗操作相关的不良反应中。结论：临床应用司维拉姆时，应关注代谢与营养类疾病相关不良反应，并采取相应的预防措施，保障患者用药安全。

Abstract: Objective: Based on the FAERS database, to systematically mine and quantitatively evaluate the adverse event signals of Sevelamer in the background of peritoneal dialysis medication, identify potential risk characteristics, and provide evidence-based basis for optimizing the clinical safe medication decisions of this population. Methods: The data of Sevelamer from the first quarter of 2004 to the first quarter of 2025 in the Adverse Event Reporting System (FAERS) database of the US FDA were extracted. The data were mined by reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multiple gamma-Poisson contractile (MGPS). And the ADE signal mining results were systematically classified through Edition 26.1 of the “International Dictionary of Medical Terms”. Results: A total of 1002 ADE reports with Sevelamer as the primary suspicion were retrieved, with a male-female ratio of 1.3:1. The age of the patients was concentrated in 18~85 years old (73.1%). 983 Sevelamer ADE signals were detected, involving 28 SOC. Among the top 10 PT in terms of the number of reports, there were 3 suspected positive signals not recorded in the instructions, mainly concentrated in metabolic and nutritional diseases, systemic diseases, reactions at the administration site, and adverse reactions related to various surgeries and medical procedures. Conclusion: When applying Sevelamer clinically, attention should be paid to the adverse reactions related to metabolic and nutritional diseases, and corresponding preventive measures should be taken to ensure the safety of patients’ medication.